Aphthous ulcers, often referred to as canker sores, are characterized by painful eruptions in the mucous membrane of the mouth. Of unknown etiology, they are covered by a grey exudate, and surrounded by a reddened area. They range in size from several millimeters to two centimeters in diameter. The ulcers are limited to oral mucous membranes not bound to periosteum, e.g. the inner portion of the lip or cheek. Aphthous ulcers may occur as solitary or multiple lesions, and heal spontaneously in one or two weeks. (Steadman's Medical Dictionary, 25th Ed., Williams & Wilkins)
Other mucocutaneous disorders can also result in the formation of oral ulcers that can be extremely painful.
Therapy for mouth ulcers generally involves use of topical anesthetics such as benzocaine in preparations made with a carrier designed to protect the ulcer from saliva and hold the anesthetic at the site. Zilactin is a topical medication composed of hydroxypropylcellulose, salicylic, lauric and tannic acids which has mucosal adherence properties. The mode of action of the product appears to be its effective film-forming capability that insulates the ulcer from the mouth environment. Because this characteristic requires effective formation of such a film, the product is difficult to apply in a manner sufficient to optimize its effect.
Still lacking is a method of treating aphthous ulcers and other mucocutaneous disorders which is easier to apply and which actually speeds the healing of the ulcers. These objectives are achieved by the present invention, which involves the use of oral pastes, troches and mouthwashes which contain as an active ingredient, amelexanox and its analogs.
As disclosed in U.S. Pat. No. 4,143,042, amlexanox is a compound of the formula 2-amino-7-(1-methylethyl)-5-oxo-5H[1]benzopyrano(2,3-b)pyridine-3-carboxyl ic acid. Amlexanox and its homologs and analogs are known to have anti-allergic activity, and are of value as prophylactic and curative drugs for the treatment of allergic asthma, allergic dermatitis, hay fever and other allergic diseases in mammals, including humans. In Chemical Marketing Reporter, Aug. 14, 1989, it was reported that tests were under way to test use of amlexanox on mouth ulcers. No results were provided.